NaturaLyte recallZ-1311-2022 · Fresenius Medical Care Holdings, Inc. · initiated Jun 1, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Fresenius Medical Care Holdings, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging. Leaks can lead to biological contamination and therefore an increased risk of potential bloodstream infection.
FDA root cause category: Under Investigation by firm
What the company is doing
On June 1, 2022, the firm reached out to its affected customers via telephone to explain the product issue. Customers were instructed to identify and segregate the affected product immediately and remove the product from inventory. If customers had any product to return, the recalling firm would have a customer service representative follow up with the customer. Customers were reminded to always inspect packaging for leaks.
Recall details
- Recall number
- Z-1311-2022
- Status
- Terminated
- Initiated by the company
- Jun 1, 2022
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Quantity
- 3 cases
- Product code
- KPO
- FDA submissions
- K192017
- Distribution
- US Nationwide distribution in the states of Texas and Louisiana.
Product description
NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3
Code information (models, lots, serial numbers)
UDI: (01)00840861101702 (17) 230131 (10) 21AGAC009 Lot 21AGAC009
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NaturaLyte 08-2301-3Fresenius Medical Care Renal Therapies Group, LLC · DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)2 recalls35 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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